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No Benefit from Raloxifene for CHD, Fatal Stroke Risk Up

Study shows breast cancer down, but fatal stroke and venous thromboembolism up

WEDNESDAY, July 12 (HealthDay News) -- The selective estrogen-receptor modulator raloxifene reduces the risk of invasive breast cancer but does not prevent coronary heart disease (CHD) and increases the risk of venous thromboembolism and fatal stroke, according to the Raloxifene Use for The Heart (RUTH) trial results published in the July 13 issue of the New England Journal of Medicine.

Elizabeth Barrett-Connor, M.D., of the University of California San Diego in La Jolla, Calif., and RUTH trial members randomized 10,101 postmenopausal women with CHD, or with risk factors for CHD, to either 60 milligrams of raloxifene daily or a placebo, then measured the incidence of coronary events and invasive breast cancer. Average follow-up was 5.6 years.

While raloxifene reduced the risk of invasive breast cancer by 44 percent and helped prevent vertebral fractures, it showed no effect on CHD incidence in women with or at-risk for CHD. In addition, the risks for venous thromboembolism and fatal stroke were up by 44 percent and 49 percent, respectively.

The results suggest considering a careful risk-benefit analysis before recommending raloxifene or another selective estrogen-receptor modulator, like tamoxifen, for individual women, according to Marcia L. Stefanick, Ph.D., of the Stanford School of Medicine in Stanford, Calif. "For now, there is no magic bullet that can reduce the risks of major health problems related to estrogens and aging without introducing other potentially serious health concerns," she writes in an accompanying editorial.

The study was supported by Eli Lilly.

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